Are you a professional experiencing difficulties to put your medical device on the EU market. Are you desperately waiting for your official certificate from your Notified Body. Or did you submitted a major change of your product and waiting for the decision from your notified body? So you are like the majority of the new created companies impacted by this change.
With PIP scandal and the need to change the rules to put a medical device on the market, we were all supportive of the need for implementation of new regulations and also a better control of the notified bodies. But guess what, I am not really sure that the strategy was well defined.
Here is a small true story talking about a new company wanting to sell products in EU. Names and locations were modified.
CHAPTER 1: At the Medical Device Company HQ
An engineer called Carl was pressed by his organization to improve the level of their Quality System to obtain the ISO 13485 certification and the CE Certificate so he can sell his products all over the world.
It took him 6 months to finalize his objective and 2 months before the end, he called a notified body named NB to get a date for the certification audit. Ok the date is planned for July. Then Carl prepared his planning for his Executives and informed them that they should receive the official certificate by September due to holidays. And then the registration of the products in EU will be able to start.
In July, the multinational company invested a bit of money to get 3 Subject Matter Experts from the headquarter of the organization travelling to Europe to support the new entity. There were also people from different department coming from Belgium, Germany and France. The day before the audit, the team was fixing the last documents and providing their last recommendation. Everybody was really excited and really confident on the outcome of the audit.
Carl’s phone was ringing. He answered:
– “Hi”
A voice at the end replied
– “Hi, my name is Tania Smith from NB. I am calling you because the auditor is sick so we have to cancel the audit. There is no other auditor available to replace him. We will come back to you with another date as soon as possible. Sorry for this. Have a nice day”.
The Engineer is looking at the others who didn’t notice what is happening. He started to turn white. An assistant came to him to ask for how many people we should prepare the lunch tomorrow. He stood-up and told the all team.
– “Hey guys, I just got a call from the Notified Body and the audit is cancelled as the auditor is sick. I am really sorry for that” Everybody were shocked.
All this investment to get people on-site, the money paid to prepare all this. His boss will not be happy.
Carl tried to contact again the notified body to plan another date. He mentioned to them that the second week of September would suit the team. It will be after the holiday period so everybody should be back. He was told by NB that they will come back to him with a confirmation.
Carl came back from his holidays the last week of August. During all his holidays he tried to call NB to get a confirmation. but he didn’t got a formal answer. The week before the audit as still no answer was arriving, Carl cancelled the audit by himself to avoid people travelling again for nothing.
CHAPTER 2: Notified Body Reality
Disgusted by this situation, Carl tried to understand what is happening. Why a Big Notified Body as NB cannot be available. Carl participated to a training on the rules under discussion for the new EU Medical Device Regulation. During this training, he discovered that also rules to become a Notified Body have changed. The result is that not so much of them can comply with them. So they disappear. During the training there was a figure compiled by an organization named Medidee Services SA with the number of Notified bodies few years ago, the present situation and a prognosis for the future. The number shrinked and this is only the beginning. He can see that by 2016 there will be half of the Notified Bodies that will close.
So Carl understood that this will get worst. He can see why NB was overloaded with a lot of requests from his customers. He also learned that because of this new rule to perform unexpected audits Notified Bodies like NB do not have enough resources and even contractors are rare. There is a war happening now to get independent auditor working for them.
CHAPTER 3: Which Notified Body to choose
Carl asked himself, what will happen if the Notified Body he choose in a near futur will not be able to respect the new rules. What will happen to his certificate. Will he be able for a certain period of time to deliver his products. The answer is that everything will disappear. The first priority then will be to find under a high priority a new Notified Body.
After few months, finaly in November Carl has been audited and performed well. Apparently, even if the auditor says that the company will normally be certified there is another step. A board meeting at the Notified Body will confirm this by reviewing all the documents. But the problem for Carl is that he will need to wait a minimum of 3 months before to get this Board Meeting decision. WHAT ???
Ok, so even to confirm the certificate there is a bottleneck. Incredible. Carl was thinking that he will be able to start the registration of the products by March when initially it was planned for September the previous year. 6 months of lost, it’s a hudge amount of money. This will be difficult to recover when all the forecast were already planned. The manufacturing of the products already started and the cherry over the cake is that those do have an expiry date so what to do with the stock built.
CONCLUSION
We are not against improvement on regulation but we think that there should be also a strategy in place to avoid situation where all the mechanic is slowing down. A signal should have been in place to the market to get more ressources to thoses private entities called Notified Bodies that are supporting healthcare companies.
One of the outcome of that story is, if you are looking for a job, get trained to be an Auditor. Notified Bodies are looking for you as they have no choice and healthcare companies need you also to be able to sell their products. Please help our entities to get certified.
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Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
Summary
Article Name
Poor Notified Body... Poor us
Description
A new obligation to perform an unannounced audit with Medical Device manufacturer created a lot of problems to any notified body. Resources not available.
Author
El Azzouzi Monir
Publisher Name
Easy Medical Device
Publisher Logo
